Apparatus for taking multiple fluid samples



Sept. 30, 1969 J. R. NEHRING 3, 7

APPARATUS FOR TAKING MULTIPLE FLUID SAMPLES Filed Aug. 18, 1966 A 2 Sheets-Sheet 22 5 3o I I I M 35 5g 75% 3 20 29 7/ ,(QQHDMIQFM F /G .2 INVENTOR' Sept. 30, 1969 J. R. NEHRING 3,

APPARATUS FOR TAKING MULTIPLE FLUID SAMPLES 2 Sheets-Sheet 2 Filed Aug. 18, 1966 F/G/l FIG/2 F/G. /3

INVESTOR.

United States Patent 3,469,572 APPARATUS FOR TAKING MULTIPLE FLUID SAMPLES John Richard Neln'ing, Linden, N.J., assignor to Becton,

Dickinson and Company, Rutherford, N.J., a corporation of New Jersey Filed Aug. 18, 1966, Ser. No. 573,283 Int. Cl. A61b 5/10; A61m 25/00 US. Cl. 128-2 6 Claims ABSTRACT OF THE DISCLOSURE This invention relates to a valve assembly which will control fluid flow, particularly for use with a device for collecting multiple samples of a fluid such as blood without loss and without having to remove the venipuncture needle from the vein. The valve operation is automatic and no special operator technique is required.

When it is desired to obtain samples of a fluid, for example, blood, many problems exist. It is often necessary when making hematology studies to acquire multiple samples of blood from a patient. Repeated punctures of a vein in order to collect the required multiple samples is painful to the patient and could cause collapse of the vein. Also, where a needle is allowed to remain in the vein, a special device which would include a valve would have to be attached to the needle to prevent loss of blood during the period when blood collection containers are changed. If no valve device is employed, the .blood that would flow during the period when the collection containers are changed, could cause soaking of the bed linen and the patients garment. It could also psychologically upset the patient and thus add to his discomfort.

Special operator techniques developed to lessen the blood loss when no valve is used, during the changing of collection containers, also have created some problems. For instance, when the operator occludes the needle against the lumen of the vein, the pointed tip often passes through the vein which requires a repuncture of the vein which adds to the pain and discomfort to the patient.

When the available types of built-in valves are used, the operator is required to manipulate the valves to open and close them and therefore his hands are occupied and cannot be used to accomplish other required tasks. Also, many of the valves available are expensive to manufacture and are difficult to use. This prohibits the disposability of the valve after use and creates the necessity for resterilization processes.

It is therefore an object of this invention to provide a valve assembly which will alleviate the above-mentioned problems.

Another object of this invention is to provide a valve assembly for use in controlling the flow of a fluid from a fluid source to a collection container.

Another object of this invention is to provide a valve assembly for use as part of a multiple fluid sampling device thereby facilitating the collection of multiple samples of a fluid without loss.

A still further object of this invention is to provide ice a valve assembly for use with a multiple fluid sampling device whereby when the valve is opened, no external pressure or other manipulation is necessary to keep it open and as a result the operators hands are free for performing other required tasks.

Still a further object of this invention is to provide a valve assembly for use with a multiple fluid sampling device, for sampling a fluid such as blood, which is entirely automatic, requires no additional equipment for its operation, and requires no special operator techniques.

Still a further object of this invention is to provide an automatic valve assembly for use with a multiple fluid sampling device which enables a venipuncture needle to remain located in the vein during the collection of multiple samples of blood without loss of blood and without the necessity of repeated punctures.

Still a further object of this invention is to provide an automatic valve assembly for use with a multiple fluid sampling device which is simple in construction, is positive and fast acting and is constructed of low oost materials, the result being a needle assembly which is economic to produce, is eflicient to use, and can be disposed of after single use thereby eliminating the need for extensive resterilization processes.

I have provided in this invention an automatic valve assembly having a hollow shaft with means on one end for connection to a fluid source and a valve closure assembly mounted on the shaft which normally covers the opening and prevents the flow of fluid through the shaft to the collection container, which may therefore be used to control the flow of a fluid from a fluid source to a collection container. It is adaptable for use as part of a device for collecting multiple samples of a fluid. The valve is designed so that it will automatically open the passage for the fluid to flow when a collecting means is attached and will automatically close the passage for the fluid flow when the collecting container is detached.

With these and other objects in mind, reference is had to the attached drawings illustrating the invention in which:

FIG. 1 is a partially sectional and partially phantom elevation view of a valve assembly which embodies this invention depicted in connection with a collecting tube and holder assembly;

FIG. 2 is an enlarged partially sectional view of the valve means of the invention;

FIG. 3 is a cross-sectional view taken in the direction of the arrows of line 3-3 of FIG. 2;

FIG. 4 is a fragmentary elevational view of one end of the cannula of FIG. 2;

FIG. 5 is a partially sectional side elevation view of one end of another embodiment of the invention with the remainder broken away and removed;

FIG. 6 is another view of FIG. 5 rotated FIG. 7 is a sectional elevation view of another embodiment of a flexible sleeve portion forming a part of the valve assembly;

FIG. 8 is a [fragmentary elevational view of an alternate cannula tip for the embodiment shown in FIG. 5;

FIG. 9 is another View of FIG. 8 rotated 90;

FIG. 10-FIG. 13 are sectional elevation views of the collection assembly of FIG. 1 depicting the operational steps required when using the invention to collect multiple samples of blood.

FIG. 1 shows the invention .as part of a needle assembly connected to a conventional holder for an evacuated collecting tube which is shown positioned at the rear end of the holder. A double ended cannula 20 is used and in this embodiment is shown having two pointed ends 21 and 21'. The cannula is housed and sealed within bore 73 of hub or housing 70 located between the cannulas ends. Hub 70 has a threaded outer surface 71 on one end and a non-threaded outer surface 72 on the other end. Non-threaded end 72 of hub 70 is adapted to receive a sheath 25 to encompass and protect the uncovered forward portion 22 of cannula 20. Sheath 25 fits on and is held in frictional engagement with non-threaded surface 72 of hub 70. Threaded end 71 of hub 70 may be interengaged with a threaded bore of a conventional collection tube holder 40 adapted to receive valve assembly 29. Holder 40 may be of a conventional type for receiving an evacuated collecting tube 50 having a self-sealing puncturable diaphragm or stopper 60 at its open end.

Rear portion 23 of cannula 20 which extends from the threaded end 71 of hub 70 is shown being housed within holder 40 after holder 40 has been interengaged with hub 70. An elastomeric sleeve 30 encompasses the majority of the outer surface of rear portion 23 of cannula 20 which extends from threaded end 71 of hub 70. Sleeve 30 has an inner diameter which is smaller than the outside diameter of cannula 20 which results in frictional engagement between the sleeve and the cannula.

The outside diameter of sleeve 30 is such that it abuts against the rear surface of hub 70 and will not be forced from cannula 20 onto hub 70 as it is being collapsed.

FIG. 2 shows .an enlarged sectional view of valve assembly 29. Valve assembly 29 comprises cannula 20 which mounts a flexible, resilient elastomeric sleeve 30 thereon. Elastomeric sleeve 30 may be formed of any suitable material which exhibits flexible resilient properties, for example, natural or synthetic rubber or any suitable elastomeric, polymeric material such as silicone rubber. Sleeve 30 abuts the rear surface of hub 70 and extends almost the full length of rear portion 23 of cannula 20. The bore opening at the rear tip 21 of cannula 20 is sealed by a plug 35. Plug 35 may be of a plastic material such as an epoxy resin or of any other suitable type of sealing material such as latex, wax, or any metallic material.

A side opening 31 is provided adjacent the sealed end of cannula 20 as is shown most clearly in FIG. 2. When sleeve 30 is in its relaxed position it occludes side opening 31 in cannula 20 thereby forming a valve closure means to prevent fluid from flowing through opening 31.

FIGS. 5 through 9 illustrate an alternative of a valve assembly in which rear tip 32 of cannula 20 is sealed by mechanical deformation such as by crimping, soldering, brazing or welding. When sealing cannula 20 in this manner tip 32 is formed having a relatively pointed end and requires no plug to act as a seal. The shape of the tip in FIGS. 5 and 6 and the shape of the tip in FIGS. 8 and 9 are representative of the many types of deformed tips possible. Mechanically deformed tips have an advantage over other plugged or non-plugged standard cannula tips in that shapes such as those shown greatly reduce the stopper penetration and removal force otherwise required. This action significantly reduces patient discomfort and facilitates operator technique. Also, in order to insure proper frictional engagement between sleeve 36 and cannula 20 the rear end of sleeve 36 is formed having a concave surface which is complementary to a portion of deformed tip 32 as seen in FIG. 5. Forward end of sleeve 36 may likewise be formed having a complementary concave surface 37 so as to facilitate the collapsing of sleeve 36 as illustrated in FIG. 7. There are many other alternative methods of sealing end 32 of cannula 20 which will be obvious to those skilled in the art. For instance, the elastomeric sleeve is self-sealing and puncturable and therefore may be extended to cap the end of the cannula thereby forming a seal. Then, when sleeve 30 is collapsed, the pointed end of the cannula will puncture the sleeve thus exposing the open rear end of the cannula.

FIGS. 10 through 13 depict the actual operational steps which are required for the collection of a fluid such as blood when this invention has been connected to a conventional holder 40 used in conjunction with an evacuated collecting tube 50 having a puncturable self-sealing di- 'aphragm 60 mounted on its open end. Also it is obvious 4 that the valve assembly illustrated in FIGS. 5-9 may be employed in a similar manner as valve assembly 29 as shown in FIGS. 1-3. For explanation purposes, blood will be used as the fluid being collected. however, various other types of fluids may be collected by employing the valve assembly of the invention described herein.

FIG. 10 shows the invention assembled prior to use.

As can be seen, hub 70 is threadedly engaged with holder 40. Elastomeric sleeve 30 is in its relaxed position and occludes side opening 31 of cannula 20 to maintain valve assembly 29 in a closed position. Turning to FIG. 11, the arrow shows the direction of movement of evacuated collecting tube 50 which has been moved within the holder 40 until it contacts pointed rear end 21 of cannula 20. Diaphragm '60 of collecting tube 50 is punctured by pointed rear end 21 of cannula 20 and sleeve 30 is partially collapsed by the force of diaphragm 60 as it moves relative to cannula 20. In the position shown, cannula 20 is partially within diaphragm 60 of collecting tube 50, and will remain in this position without the necessity of an external force. Side opening 31 of cannula 20 is occluded, in this position, by diaphragm 60 in place of elastomeric sleeve 30 which has been partially displaced and collapsed. The assembly when in this position is normally ready for entry into a vein prior to collecting a sample of blood. Venipuncture end 21' of cannula 20 is then inserted into vein 51.

FIG. 12 shows the position of the elements of the assembly With venipuncture end 21 inserted in vein 51 when blood is actually being collected in collecting tube 50. Diaphragm 60 which previously sealed side opening 31 has been moved forward to completely collapse sleeve 30 and as a result, the rear end of cannula 20 has extended through diaphragm 60. Cannula 20 has sufficient length so that both its pointed plugged end and side opening 31 now extend beyond diaphragm 60 into evacuated collecting tube 50. Blood can now flow from vein 51 through the bore of cannula 20 and the side opening 31 into collecting tube 50. The parts of the entire assembly will remain in the position depicted in FIG. 12 without the use of any external force until the needed amount of blood is collected. Evacuated collecting tube 50 is maintained in position by the frictional engagement of diaphragm 60 and cannula 20. The operators hands are then free to conduct any other procedure necessary to facilitate the collection of the blood or any other required task. It should be noted that by merely regulating the position of diaphragm 60 along cannula 20, the rate of flow of blood can be controlled by varying the amount of side opening 31 occluded.

When the required amount of blood has been collected in evacuated collecting tube 50, the tube is removed as shown in FIG. 13. The arrow shows the direction of removal of evacuated collecting tube 50 as it is withdrawn from holder 40. As diaphragm is withdrawn from cannula 20, it occludes side opening 31 thereby stopping the flow of blood from vein 51 into collecting tube 50. In addition, as diaphragm 60 is removed, elastomeric sleeve 30 returns to its relaxed position, where it will once again occlude side opening 31 and prevent blood from flowing from the rear end of cannula 20. This entire operation can be accomplished without loss of blood. The venipuncture end of cannula 20 need not be removed from the vein 51. Another evacuated collecting tube may be introduced into holder 40 and another sample taken as previously described.

No special operator technique is required and the entire operation of the valve assembly is automatic. The valve assembly is included in the structure of the collecting apparatus and therefore no additional external connections or valves need be attached. As many samples as required during a phlebotomy may be taken without changing the needle assembly used to collect the blood. The venipuncture need only be made once and the cannula will remain in the vein as long as required. The valve assembly is constructed of low-cost material and is economical to produce, thereby lending itself to disposability after a single use which eliminates the need for extensive resterilization procedures.

Thus, the above-mentioned objects of the invention, among others, are achieved, The range and scope of the invention are defined in the following claims.

I claim:

1. A device for facilitating the collection of multiple fluid samples in a multiple of fluid collection containers wherein the multiple fluid samples are collected upon mounting the fluid sampling device in situ on the body with a single penetration of the body walls, the fluid device comprising:

a needle assembly having a forward penetrating end for penetration into the body walls;

means for coupling said assembly with a holder for directing the multiple fluid sample containers in coupling relationship with the needle assembly;

the needle assembly having a rearward end for coupling with the sample container and adapted to being in fluid communication with the interior of the container when the container is mounted for association therewith;

the needle assembly having a passage network for directing liquid from the body to the collection container;

said needle assembly including a housing having a passage therethrough, a double ended cannula mounted in said passage so that both ends of the cannula extend therefrom, one end of said cannula forming the forward penetrating end for penetration into the body walls and the other end of said cannula forming the rearward end for coupling with the sample container;

a valve mounted on said needle assembly and being adapted to assume a first position prior to coupling of the sample collection container to close the passage network of the needle assembly and adapted to be shifted to a second position at which it opens the passage network of the needle assembly to permit the liquid to pass from the body when said sample collection container is coupled to said needle assembly and adapted to return to the first position when the sample collection container is removed from said needle assembly; and

said valve including a thin walled sleeve of elastomeric material mounted on the other end of said cannula so as to normally cover the opening therein and close the passage network of said needle assembly and said sleeve being compressible so as to 'be shifted to said second position at which it opens the passage network of the needle assembly to permit the liquid to pass from the body and when released said elastomeric sleeve will return to its normal configura tion covering the opening in the other end of said cannula.

2. The invention in accordance with claim 1 wherein the other end of said cannula is sealed and has a side opening adjacent the sealed end communicating with the interior thereof, said sleeve of elastomeric material extending from the housing toward the sealed rear end of the cannula in surrounding frictional engagement therewith and slideable with respect thereto, said sleeve being of suflicient length to cover and close the side opening when in relaxed condition and to uncover and expose the opening when compressed toward the housing.

3. The invention in accordance with claim 2 wherein said sealed rear end includes a plug composed of an epoxy resin.

4. The invention in accordance with claim 2 wherein said sealed rear end is formed by mechanical deformation.

5. The invention in accordance with claim 1 wherein a holder is coupled with said assembly, said holder being of a hollow cylindrical configuration so as to receive a multiple fluid sample container within and directs said container into coupling relationship with said needle assembly.

6. The invention in accordance with claim 1 wherein a fluid sample container is coupled with said needle assembly, said collection container including a puncturable self-sealing stopper removably engaged with said needle assembly.

References Cited UNITED STATES PATENTS 1,767,304 6/1930 Morton 128-221 XR 2,653,607 9/1953 Deans 128-221 3,'162,195 12/1964 Dick 128-276 3,186,408 6/1965 Jacob 128-221 3,200,813 8/1965 Christakis 128-2 3,206,073 9/1965 Scislowicz 222- 3,304,934 2/1967 Bautista 128-276 XR RICHARD A. GAUDET, Primary Examiner M. F. MAJESTIC, Assistant Examiner US. Cl. X.R. 128-276 

